The New Flex Trial

New Clinical Trial Underway for Meniere's Disease

Sound Pharmaceuticals (SPI) is pleased to announce that it has completed enrollment on its first Meniere's disease (MD) clinical trial. MD is a neurotologic disease that involves episodic vertigo, fluctuating sensorineural hearing loss, and intermittent or constant tinnitus, and is thought to be due to a swelling or inflammation of the inner ear. Patients with MD may also complain of aural fullness or pressure, and in extreme cases, may require surgery to decompress the inner ear. SPI-1005, an investigational new drug that mimics and induces Glutathione Peroxidase (GPx), has been shown to reduce the swelling or edema of the inner ear in animal studies involving acoustic trauma.

According to the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS), 600,000 people in the US have MD. "We are thrilled to have completed enrollment on this ground breaking study involving Meniere's disease," said Dr. Sujana Chandrasekhar, past-President of the AAO-HNS and a study investigator. In this Phase 1b study, repeat assessments of hearing loss, tinnitus and vertigo were used to determine the safety, tolerability, and to explore the efficacy of SPI-1005 versus placebo before and after treatment. SPI-1005 was dosed orally twice daily for 21 days and has demonstrated excellent safety and tolerability to date. "We look forward to presenting these positive findings involving SPI-1005 at the Triological Society Meeting later this year," said Jonathan Kil, MD, President and CEO.

In an earlier Phase 2 clinical trial, SPI-1005 was shown to prevent sensorineural hearing loss in young adults exposed to noise. These AAO-HNS presented findings have now been accepted for publication by a prestigious medical journal. Taken together, these results suggest a broad potential for SPI-1005 in the treatment of several types of sensorineural diseases of the inner ear. Currently, there are no FDA approved drug treatments for MD, or any other neurotologic disease. According to the CDC, sensorineural hearing loss is the third largest chronic disease and affects over 31 million adults in the US. Tinnitus, is the abnormal perception of sound, and affects 10-15 percent of adults according to the AAO-HNS. Vertigo is an abnormal perception of balance, and can involve a sense of spinning or the sensation of movement in the absence of movement.